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NCT03974945 · ClinicalTrials.gov registry record
Does Walking Performance Improve When Veterans With Leg Amputations Are Given Visual Feedback?
A clinical trial of Amputation, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- 12
- Enrollment target
- 1
- Study location
NCT03974945: Completed study of Amputation, sponsored by VA Office of Research and Development.
NCT03974945 is a study of Amputation that has completed, run by VA Office of Research and Development. The registered enrollment target is 12 participants, below the 133-participant average among 65 other Amputation trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03974945, a study of Amputation, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
Previous studies suggest that Veterans with below the knee amputation using passive-elastic or powered prostheses have impaired physical function, which could increase the risk of osteoarthritis, leg/back pain, and diabetes/obesity. Utilization of rehabilitation strategies/techniques such as real-time visual feedback training could restore physical function, increase physical activity, and reduce injury risk. The investigators will systematically determine the effects of using real-time visual feedback training of peak propulsive (push-off) force during walking while Veterans with below the knee amputations use a passive-elastic and battery-powered prosthesis. Similar to previous studies of non-amputee older (\>65 years) and post-stroke adults, use of real-time visual feedback training of propulsive force will likely improve walking function in Veterans with amputations. Such training presents a promising rehabilitation strategy that could reduce comorbidities, while improving quality of life, comfort, and physical function, and advancing rehabilitation research and prosthetic development.
Primary Outcome
The investigators measured peak propulsive horizontal ground reaction force (hGRFpeak) from the affected leg while participants with a transtibial amputation walked at 1.25 m/s for 18 trials that were 5 minutes each over 3 separate days using an elastic energy storage and return (ESAR) and stance-phase powered ankle-foot (BiOM) prosthesis. During the first trial we measured their baseline hGRFpeak and then for the subsequent trials we provided a trial with visual feedback (FB) targets of hGRFpea
Conditions Studied
Interventions
- DEVICE Passive-elastic prosthetic foot
- DEVICE Powered ankle-foot prosthesis
Study Locations (1)
Colorado
- Rocky Mountain Regional VA Medical Center, Aurora, CO - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2019-08-01 |
| Est. Completion | 2024-05-14 |
What the finished NCT03974945 record still lists
NCT03974945 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 65 other Amputation trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Amputation appearing as the primary indexed condition, and to 2 interventions - of which Passive-elastic prosthetic foot is the first listed.
NCT03974945 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT03974945 about?
NCT03974945 is a clinical study titled "Does Walking Performance Improve When Veterans With Leg Amputations Are Given Visual Feedback?". Previous studies suggest that Veterans with below the knee amputation using passive-elastic or powered prostheses have impaired physical function, which could increase the risk of osteoarthritis, leg/back pain, and diabetes/obesity. Utilization of rehabilitation strategies/techniques such as real-ti...
What is the current status of trial NCT03974945?
This trial is currently completed. The enrollment target is 12 participants. The study started on 2019-08-01. Estimated completion is 2024-05-14.
What conditions does trial NCT03974945 study?
This clinical trial studies the following conditions: Amputation.
What interventions are being tested in trial NCT03974945?
The interventions under investigation include: Passive-elastic prosthetic foot (DEVICE), Powered ankle-foot prosthesis (DEVICE).
Who is sponsoring clinical trial NCT03974945?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03974945 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03974945's enrollment target sits among peer trials
12 48th of 65 higher than 18 of 65 other Amputation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Amputation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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